EU-SolidAct
European DisCoVeRy for Solidarity: an Adaptive Pandemic and Emerging Infection Platform Trial.The EU-SolidAct trial – European DisCoVeRy for Solidarity: An Adaptive Pandemic and Emerging Infection Platform Trial – is part of EU-RESPONSE, a pan-European research project involved with the rapid and coordinated investigation of medications to treat COVID-19 during the ongoing pandemic. The EU-SolidAct (EudraCT: 2021-000541-41; clinicaltrials.gov ID NCT04891133) is a multi-center, randomized, adaptive Phase 2 and 3 platform trial, the master protocol of which has been developed to evaluate potential treatments in hospitalised patients with COVID-19, the disease caused by the SARS-CoV2 virus (coronavirus). Under the trial, bemcentinib will be studied in up to 500 hospitalised COVID-19 patients. In support of the trial, BerGenBio will provide bemcentinib drug material and incremental funding of costs related to the bemcentinib sub-protocol.
The first drug studied under the EU-SolidAct platform was baricitinib, marketed by Eli Lilly and Company, and is now under market authorisation evaluation by the EMA (European Medicines Agency) for use in hospitalised COVID-19 patients. BerGenBio’s AXL inhibitor, bemcentinib, has been selected by an international expert group to be the second compound to be studied in the EU-SolidAct platform.
EU-SolidAct has established clinical sites in 15 countries. The trial is sponsored by Oslo University Hospital, Norway in collaboration with the Institut National de la Santé Et de la Recherche Médicale (Inserm), France and the not-for-profit intergovernmental organization European Clinical Research Infrastructure Network (ECRIN). The trial through the EU-RESPONSE project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 101015736. Individual patient-level data will be made as public as possible while maintaining the integrity and privacy of the trial participants.
Population: adult
